Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy

February 26, 2019 updated by: Allergan

BOTOX® Treatment of Masseter Muscle Hypertrophy

This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Shape Clinic
      • Sydney, New South Wales, Australia, 2000
        • Central Sydney Dermatology
    • Queensland
      • Main Beach, Queensland, Australia, 4217
        • Esteem Beauty & Day Spa
    • Western Australia
      • North Fremantle, Western Australia, Australia, 6159
        • The Rose Medical & Aesthetic Centre
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Dr. Jean Carruthers Cosmetic Surgery, Inc.
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Dr. Shannon Humphrey Inc.
      • Vancouver, British Columbia, Canada, V6H 1K9
        • Project Skin MD
      • Vancouver, British Columbia, Canada, V6H 4E1
        • Pacific Dermaesthetics
    • Ontario
      • Woodbridge, Ontario, Canada, L4L 8E2
        • Bertucci MedSpa
    • Quebec
      • Montreal, Quebec, Canada, H3Z 1B7
        • Arthur Swift Research Inc.
  • Taiwan
      • Kaohsiung, Taiwan, 80735
        • Kaohsiung Medical University Hospital
      • Taipei, Taiwan, 10041
        • National Taiwan University Hospital
      • Taipei, Taiwan, 10507
        • Taipei Chang Gung Memorial Hospital of CGMF
      • Taipei, Taiwan, 11411
        • Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Participants with Masseter Muscle Hypertrophy

Exclusion Criteria:

  • Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
  • Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face
  • History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
  • History of or current temporomandibular joint disorder (TMJD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BOTOX® 24U
Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Biological: botulinum toxin Type A
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Active Comparator: BOTOX® 48U
Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Biological: botulinum toxin Type A
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Active Comparator: BOTOX® 72U
Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Biological: botulinum toxin Type A
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Active Comparator: BOTOX® 96U
Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Biological: botulinum toxin Type A
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Placebo Comparator: Placebo
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Drug: Normal saline
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Lower Facial Volume Using VECTRA 3D Images
Time Frame: Baseline (Day 1) to Day 90 of Treatment Cycle 1
Lower facial volume was calculated from 3-dimensional (3D) images captured with the VECTRA M3 3D Stereophotogrammetry imaging system and was analyzed using computer assisted systems and predetermined facial landmarks. The difference in volume was measured between the select region of the baseline surface 3D model and the select region of the posttreatment surface 3D model. A negative change from Baseline (decrease in volume) indicates improvement.
Baseline (Day 1) to Day 90 of Treatment Cycle 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator
Time Frame: Day 90 of Treatment Cycle 1
The investigator used visual inspection and palpation to grade the prominence of the participant's masseter muscle on the left and right sides of the face using the MMPS where: 1=minimal prominence (best), 2=mild prominence, 3=moderate prominence, 4=marked prominence, 5=very marked prominence (worst). The percentage of participants with grade 3 or less is reported.
Day 90 of Treatment Cycle 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Beta Bowen, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2014

Primary Completion (Actual)

March 7, 2017

Study Completion (Actual)

November 29, 2017

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 13, 2013

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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